(84 days)
The MDS Plating System is internal fixation of fractures of various bones such as the clavicle, olecranon. humerus, radius, ulna, distal tibia, and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage of material compatible with system implants including titanium alloy and cobalt chromium.
The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.
The MDS Plating System is an internal fixation system intenal fixation of fractures of various bones. The system consists of the following single-use implants:
- Straight (broad and narrow) and pre-contoured plates available in a variety of sizes -
- -Screws of various lengths and diameters, some of which are identified in previously cleared premarket notifications (K141493, K161292/K162635, and K162898).
- Locking Caps of various diameters identified in previously cleared premarket notifications -(K141493, K161292/K162635, and K162898).
- Low Profile Head Screws -
- -Threaded cerclage buttons of various diameters used in conjunction with MDS plates to augment fracture stabilization.
Additionally, the system includes single use and reusable instruments.
Materials: Titanium alloy and Stainless Steel.
This document describes a 510(k) premarket notification for the "MDS Plating System," a medical device for internal fixation of bone fractures. As such, the FDA's review for substantial equivalence primarily relies on non-clinical performance data and comparison to predicate devices, rather than clinical studies with acceptance criteria in the typical sense of AI/Dx devices.
Therefore, the requested information elements related to clinical studies, ground truth establishment, expert adjudication, and specialized sample sizes (training/test sets for algorithms) are not applicable in this context. The data provided focuses on mechanical and material performance testing.
Here's an interpretation of the available information in the context of the device and regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance
For devices like the MDS Plating System, acceptance criteria are generally established based on recognized industry standards for mechanical performance and material properties. The "reported device performance" refers to the results of tests demonstrating compliance with these standards and comparability to predicate devices.
| Acceptance Criteria Category | Specific Criteria (Derived from Standards) | Reported Device Performance |
|---|---|---|
| Material Properties | Biocompatibility, mechanical properties (e.g., tensile strength, fatigue resistance) of Titanium alloy and Stainless Steel. | Not explicitly detailed in the summary, but implied through "material, design, indications for use, and performance characteristics" equivalence to predicates. Compliance with standards for these materials is expected. |
| Plate Mechanical Strength | ASTM F382-99: Standard Test Method for Metallic Medical Bone Plates (e.g., bending strength, stiffness for various plate designs and sizes). | "Testing according to ASTMF382-99" demonstrates performance comparable to predicate devices. The system "performs as well as the predicate devices." |
| Screw Mechanical Strength | ASTM F543-07: Standard Specification and Test Method for Metallic Bone Screws (e.g., torsional strength, pull-out strength, bending strength). | "Testing according to ASTM F543-07" demonstrates performance comparable to predicate devices. The system "performs as well as the predicate devices." |
| Design Equivalence | Comparison to predicate devices for overall design, dimensions, and intended use. | "Documentation is provided which demonstrates that the MDS Plating System is equivalent to its predicate devices in terms of material, design, indications for use, and performance characteristics." |
| Sterilization & Packaging | Sterility assurance level (SAL), packaging integrity. | Not explicitly detailed in the summary, but implied through general good manufacturing practices and regulatory requirements for medical devices. |
2. Sample Sizes Used for the Test Set and Data Provenance
This is not applicable as there isn't a "test set" in the sense of an AI algorithm or diagnostic device. The performance testing involves mechanical and material tests performed in a laboratory setting. There are no "patients" or "data provenance" (country of origin, retrospective/prospective) in this context. The "samples" would be the manufactured device components (plates, screws, etc.) subjected to mechanical testing. The sample size for such tests is typically determined by relevant ASTM standards to achieve statistical significance for the mechanical properties measured.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. For mechanical performance testing of orthopedic implants, "ground truth" is defined by established engineering principles and measurements against recognized standards (e.g., ASTM). No human "experts" are establishing diagnostic ground truth for a test set.
4. Adjudication Method for the Test Set
This is not applicable. There is no human adjudication process involved in assessing the mechanical performance against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The MDS Plating System is a surgical implant, not a diagnostic tool or an AI-assisted diagnostic system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance test in the context of an algorithm was not done. Again, this device is a surgical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering standards and physical measurements. This includes:
- Mechanical Test Results: Direct measurements of tensile strength, torsional strength, bending strength, fatigue life, etc., obtained through laboratory testing.
- Material Specifications: Compliance with established properties for titanium alloy and stainless steel as per international standards.
- Design Specifications: Conformance to detailed engineering drawings and specifications.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" for an AI algorithm in this context.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as point 8.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.